CN105025960A - State changing appliance for a drug delivery device - Google Patents

State changing appliance for a drug delivery device Download PDF

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Publication number
CN105025960A
CN105025960A CN201380067067.0A CN201380067067A CN105025960A CN 105025960 A CN105025960 A CN 105025960A CN 201380067067 A CN201380067067 A CN 201380067067A CN 105025960 A CN105025960 A CN 105025960A
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CN
China
Prior art keywords
dose
drug delivery
delivery system
relative
state
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CN201380067067.0A
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Chinese (zh)
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CN105025960B (en
Inventor
M.S.斯特芬森
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Novo Nordisk AS
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Novo Nordisk AS
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Publication of CN105025960A publication Critical patent/CN105025960A/en
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Publication of CN105025960B publication Critical patent/CN105025960B/en
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31525—Dosing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31535—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
    • A61M5/31536—Blocking means to immobilize a selected dose, e.g. to administer equal doses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31566—Means improving security or handling thereof
    • A61M5/31573—Accuracy improving means
    • A61M5/31575—Accuracy improving means using scaling up or down transmissions, e.g. gearbox
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31535—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
    • A61M5/31536—Blocking means to immobilize a selected dose, e.g. to administer equal doses
    • A61M2005/3154—Blocking means to immobilize a selected dose, e.g. to administer equal doses limiting maximum permissible dose
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04C—ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT PUMPS
    • F04C2270/00—Control; Monitoring or safety arrangements
    • F04C2270/04—Force
    • F04C2270/042—Force radial
    • F04C2270/0421—Controlled or regulated

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

A system comprising a state changing appliance and a drug delivery device, the state changing appliance comprising first interface means for rotationally locking to a first exterior portion of the drug delivery device, second interface means for rotationally locking to a second exterior portion of the drug delivery device, the first exterior portion and the second exterior portion being angularly displaceable relative to one another from a first relative posi- tion to a second relative position, which second relative position defines a set dose to be expelled by the drug delivery device, and limiter means for limiting a relative angular displacement between the first interface means and the second interface means.

Description

State for drug delivery system changes apparatus
Technical field
The process that present invention relates in general to drug delivery system is assisted, and the dosage setting related more specifically to for this device is assisted.
Background technology
The device for the transmission of medicine multiple dose in major part modern times comprises dosing mechanism, and this mechanism allows user optionally to set the drug dose be assigned with from the medicine storage of drug containing.Some therapeutic schemes require to set and the medicine of the dosage giving to pass in time and change, and other therapeutic scheme then requires repeatedly to set and gives the medicine of fixed dosage.In some cases, pass in time and need adjust fixed dosage, such as interim at dose titration.
The drug delivery system of common type is a so-called pen-type injector, and this pen-type injector is the pen-formed injection device of being interrupted subcutaneous administration for active medicine.Usually, actuator can be made to rotate so that the dosage of setting expectation around all longitudinal axis by this pen-type injector user.If unexpectedly set too high dose, can by actuator reversion and by dosimeter downward until reach correct dose.
Due to the importance of correct dosed administration, this dosage setting step requires that user is paid special attention to.Some medicines are so potent so that overdose may be fatal.But for being proposed the people giving same dose at every turn, above-mentioned steps seems to go a bit too far, if this person can set given dose when not paying too much attention will be so desirable at every turn.In addition, for finding the people being difficult to the visual deterioration reading dose calibration on drug delivery system, each dosage setting can suffer the danger of terminal error process.Similarly, it is desirable in the dosage setting stage as this crowd provides larger safety.
WO 99/64092(Owen Mumford company limited/Eli Lilly company) disclose a kind of dose setting device of the personal injector for medical purpose for having dose setting knob type in syringe cylinder rear end, this dose setting knob can from clearing position transposition to be rotated to by marker just to the position of labelling scale.This dose setting device comprises the cup-shaped joint with sleeve pipe and amplifying lens.This joint is pressed into the specific angle position showing the desired amount be set and is engaged in above dose setting-knob.This joint is rotated until sleeve pipe contacts with the stud on syringe cylinder, prevents motion thus and set dosage.
Although amplifying lens can help VI to a certain extent and the program seems to avoid any possible excessive adjustment, because once joint press-in be engaged in make this knob rotate until contact with physics retainer above dose setting-knob so simply; The user of this dose setting device still must be noted when he/her sets dosage, because whether joint must be positioned at corresponding with desired amount relative in a specific angle orientation of dose setting-knob, and no matter identical for this concrete dosage of each dosage setting.In addition, because the anterior cannula rotating 360o relative to syringe cylinder at joint must adjoin stud, this device is thus utilized can not to set the dosage of the size of requirement once or more than the turn over of dose setting-knob once.
WO 01/54757(Novo Nordisk A/S) disclose a kind of dose setting limiter for dissimilar injection device, wherein set dosage by making actuator rotate around the axis perpendicular to all longitudinal axis of this device.This dose setting limiter comprises three parts, and these three parts, when being disposed in specific relative angle orientation and be installed on injection device, limit the maximal allowance dose selected in advance be set.Only have and just can select maximal allowance dose in advance when dose setting limiter is separated with injection device, one therefore in these three parts comprises the dose calibration making to select in advance to implement.
Dose setting limiter, once be located on injection device, reliably can help the repeatedly setting of the dosage of the maximal allowance dose being no more than preliminary election.But, the adjustment of the maximal allowance dose of preliminary election is impossible, because two in these three parts are for good and all fastening each other, or troublesome because these three parts all be separately and must be processed individually by user after being separated with injection device.In addition, this injection device is actually when not having dose setting display and cannot uses, because user can not see the size through adjust dosages when not having dose calibration.
Summary of the invention
An object of the present invention is at least one shortcoming eliminating or reduce prior art, or provide the useful of prior art to substitute.
Particularly, an object of the present invention is to provide the scheme of a kind of minimizing for the dosage setting step of the people that temporarily or enduringly needs specific fixed dose medication repeatedly to transmit.
Another object of the present invention is to provide a kind of scheme as above, and the program can adapt to the situation that wherein must adjust specific fixed dosage.
Another object of the present invention is to provide the dosage setting apparatus of a kind of people for temporarily or enduringly needing specific fixed dose medication repeatedly to transmit, this dosage setting apparatus help user after injection is less than one group of dosage of fixed dosage (such as, with medicine storage content empty about) remember the doses remaining that will inject.
In the present disclosure of the invention, by realizing one or more above-mentioned purpose and/or each side and embodiment that realize hereinafter described object are described.
In one aspect of the invention, provide a kind of state for drug delivery system to change apparatus, this state changes apparatus and comprises:
First, this first be suitable for and the first combined outside of drug delivery system to prevent the relative motion between first and the first outside at least one dimension, and
Second, this second be suitable for and the second combined outside of drug delivery system to prevent the relative motion between second and the second outside at least one dimension;
This first outside and the second outside relative to each other can move on to the second relative position of the second state limiting drug delivery system at least one dimension from the first-phase para-position set of the first state limiting drug delivery system,
Wherein first and second can at least one dimension relative motion, this relative motion limited by two spaced retainers.
In another aspect of this invention, provide a kind of state for drug delivery system to change apparatus, this state changes apparatus and comprises:
First, this first cage structure one-tenth rotates to interlock with the first outside of drug delivery system and is connected, and
Second, this second cage structure one-tenth rotates to interlock with the second outside of drug delivery system and is connected;
This first outside and second outside relative to each other from limiting first relative position of the first state of drug delivery system and angular displacement the second relative position to the second state of restriction drug delivery system,
Wherein first and second can there is relative angular displacement, and relative angular displacement limited by the retainer of two mutual angular spacings.
State changes apparatus and can be suitable for removably being attached to drug delivery system.Particularly, this apparatus can be adapted to be mounted within drug delivery system to change the state of drug delivery system, disassembles subsequently from drug delivery system, thus allows the further operation of drug delivery system.
Changing apparatus according to state of the present invention allows user rapidly, reliably to change the state of drug delivery system when not paying any special concern to state change step.State is changed apparatus to be such as arranged on simply on drug delivery system, make first and the first external interlock to prevent the relative motion at least one dimension between both thus, and second and the second external interlock are to prevent in the relative motion at least and in a dimension between both, thus the drug delivery system changing apparatus and a part when state relative to each other at least in a dimension from when being moved to the predetermined target location limited by another in two retainers by an initial position limited two retainers, first outside and the second outside automatically relative to each other move on to the second relative position of the second state limiting drug delivery system from the first-phase para-position set of the first state limiting drug delivery system.Therefore, when the relative motion caused by state changes between apparatus and this part of drug delivery system is suddenly stopped, user knows that the state of drug delivery system is correctly changed.
State changes the port of export (such as entry needle, needle hub or nozzle) that apparatus can be suitable for covering when being connected with the first and second outsides drug delivery system.This state changes the over cap that apparatus even can be suitable for being used as drug delivery system, and such as, except covering drug containing medicine storage at least partially, when drug delivery system is not by use, state changes apparatus and is used for dual purpose.
Apparatus can be changed to state and carry out mechanical programming, namely this state changes that apparatus can (wherein two retainers can not relative motion in non-programmable state, such as relative angular displacement) with programmable state (wherein two retainer can relative motion, such as relative angular displacement) between switch.Thus, change in state in the programmable state of apparatus, adjusted by the relative position (such as relative angular position) to two retainers, optionally can limit the degree of relative motion between first and second.
Particularly, when being installed on drug delivery system, state changes apparatus and can switch between non-programmable state and programmable state.Drug delivery system can be the device of dosage setting and transport-type; This device comprises dosing mechanism and for transmitting display from the display device of the information of one group of dosage of the medicine of wherein discharging, thus allows this device also fully can play function when not having dosage setting apparatus described herein.Particularly, drug delivery system can comprise: adopt and be suitable for experiencing the dosage indicia relative to the form of the character on the mechanical scale of the relative motion of window; Or such as, for the electronic component of show dose labelling, liquid crystal display.
First state can limit any first state of drug delivery system, and the second state can limit the free position of the drug delivery system being different from the first state.Such as, if drug delivery system comprises three medicine storages holding different pharmaceutical or different potency drug, so the first state can limit the state wherein preparing to carry the drug delivery system of certain volume medicine from specific three medicine storages, the second state can limit wherein prepare from three medicine storages another carry the state of the drug delivery system of certain volume medicine.Therefore, in this case, state changes apparatus and can go out to give to switch between medicine from each medicine storage of three medicine storages fast and easily, and this switching such as depends on that how to change apparatus to state programmes.
Particularly, first state of drug delivery system can be the state wherein not setting dosage or setting the first non-zero-dose, and the second state of drug delivery system can be wherein to the state that the dosage transferred out from medicament reservoir (the such as second non-zero-dose) sets.In this connects, state changes apparatus can be counted as the dosage setting apparatus being suitable for helping to set the given dose transmitted from drug delivery system.
Therefore, in the present invention on the other hand, provide a kind of dosage setting apparatus for drug delivery system, this dosage setting apparatus comprises:
First, this first be suitable for and the first combined outside of drug delivery system to prevent the relative motion between first and the first outside at least one dimension, and
Second, this second be suitable for and the second combined outside of drug delivery system to prevent the relative motion between second and the second outside at least one dimension;
This first outside and the second outside relative to each other can move on to the second relative position from first-phase para-position set at least one dimension, and this second relative position limits one group of dosage of being discharged by drug delivery system,
Wherein first and second can at least one dimension relative motion, this relative motion limited by two spaced retainers.
In another aspect of this invention, be provided for the dosage setting apparatus of drug delivery system, this dosage setting apparatus comprises:
First, this first cage structure one-tenth rotates to interlock with the first outside of drug delivery system and is connected, and
Second, this second cage structure one-tenth rotates to interlock with the second outside of drug delivery system and is connected,
This first outside and the second outside relative to each other can be displaced to the second relative position from first-phase to position angle, and this second relative position limits one group of dosage of being discharged by drug delivery system,
Wherein primary importance and the second position can relative angular displacements, and this relative angular displacement limited by the retainer of two mutual angular spacings.
Dosage setting apparatus can be suitable for being attached to drug delivery system separably.Particularly, dosage setting apparatus can be adapted to be mounted within drug delivery system for dosage setting and to remove from drug delivery system subsequently thus allow to set the dosage be discharged.
Because when dosage setting apparatus is connected with drug delivery system, prevent from preventing the relative motion between first and the first outside, between second and the second outside respectively in the dimension relevant with dosage setting, so the preparation that the non-programmable state of dosage setting apparatus is configured to predetermined close sets the dosage setting state provided, and the programmable state of dosage setting apparatus forms the dose titration state providing the selectivity of predetermined close to adjust.
Drug delivery system can comprise: the amount adjustor operationally connected with dosage indicia, and by the rotation (such as relative to base or the housing longitudinal axis around drug delivery system) of this amount adjustor selectivity setting dosimeter; The display of state is changed, the operation that this display regulates in response to dosage and reflect that dosage increases (when amount adjustor turns clockwise) and dosage reduction (when amount adjustor is rotated counterclockwise) (vice versa) with dosage indicia.In this case, the first outside of drug delivery system can be base or the housing of a part, and the second outside of drug delivery system can be amount adjustor.In addition, first outside and the second outside, and thus first and second also can relative to each other around longitudinal axis generation angular displacement.
Drug delivery system can have longitudinally Axis Extension, cylindrical or conical housing substantially, and dosage setting apparatus can be configured to receive one end thereof, such as, provide the coaxial alignment of dosage setting apparatus and drug delivery system.Particularly, drug delivery system can be pen-style injection devices, namely has the injection device of the structure being similar to pen.Alternately, drug delivery system can be such as dosimeter formula injection device or infusion pump, and this device has the housing being roughly box-shape in either case.
In the context of the present invention, the term " outside " used for drug delivery system represents a part that can enter outside drug delivery system.But, it should be noted specific outside without the need to fully exposing, but can such as be covered by some structures.
In another aspect of this invention, provide a kind of dosage setting apparatus for drug delivery system, this dosage setting apparatus comprises:
First interface component, for being rotatably fixed to drug delivery system first is outside;
Second interface component, for being rotatably fixed to drug delivery system second is outside, first outside is relative to each other displaced to the second relative position from first-phase to position angle with the second outside, and this second relative position limits one group of dosage of being discharged by drug delivery system, and
For limiting the limiter component of the relative angular displacement between first interface component and the second interface component.
The dosage setting apparatus of the application principle of the invention allows user reliably to set predetermined close when not paying any paying special attention to dosage setting step.Dosage setting apparatus is arranged on drug delivery system simply, first interface component and the first external engagement are to prevent the relative rotary motion between both thus, and the second interface component and the second external engagement are to prevent the relative rotary motion between both, and cause the dosage between dosage setting apparatus and drug delivery system to increase relative motion.When further dosage increase relative motion can not occur for dosage setting apparatus and drug delivery system, reach desired amount.
First interface component and the first outside can be constructed to be permeable to the rotation interlocking realized in the multiple relative angle orientation of dosage setting apparatus and drug delivery system.In addition, the second interface component and the second outside can be caused and can be realized rotating interlocking in the multiple relative angle orientation of dosage setting apparatus and drug delivery system.Such as, one in first interface component and the first outside can comprise having and such as equidistantly distribute or surface that circumference that engaged component such as roughened surface area, adhesive, hasp or enclose covers completely extends, or are suitable for receiving and hold the magnetized area of another the surface element in first interface component and the first outside.Between the second interface component and the second outside, similar interface can be set.
In multiple relative angle orientations of dosage setting apparatus and drug delivery system, be respectively used to realize providing of this component that first interface component and the first outside and the second interface component and the second outside rotation interlock, cause providing the layout of simple dosage setting fast, because no matter or in fact no matter how dosage setting apparatus all can regulate predetermined close relative to drug delivery system angular orientation when connecting with drug delivery system, namely do not require the special concern from user during both treatment dosage setting apparatus and medicine transmission.
Particularly, first interface component can comprise the spaced first interface structure of multiple circumference, and this first interface component is suitable for the first special geometry of receiving first outside.Alternately, first interface component can comprise be suitable for by one of the multiple circumferentially spaced first interface structure on the first outside the first special geometry of receiving.Correspondingly, second interface component can comprise multiple the second circumferentially spaced interface structure, this second interface structure is suitable for the second special geometry of receiving second outside, or, alternately the second interface component can comprise the second special geometry, this second geometry to be suitable for receive by spaced the second interface structure of the multiple circumferences on the second outside.
The more than one interface structure that first special geometry can be configured in the first interface structure that same time and multiple circumference are spaced is combined.Correspondingly, the more than one interface structure that the second special geometry can be configured in the second interface structure that same time and multiple circumference are spaced is combined.
First interface component can be arranged on first of dosage setting apparatus, and the second interface component can be arranged on second of dosage setting apparatus, and first and second relative to each other angular displacement can occur.
Limiter component can comprise motion limiting mechanism, and this motion limiting mechanism comprises the first stop surfaces and circumferentially spaced the second stop surfaces of the first stop surfaces and is suitable for the location marker of advancing between the first stop surfaces and the second stop surfaces.Can relative to first interface component latched position marker rotatably, and at least one in the first stop surfaces and the second stop surfaces can rotatably connect with the second interface component.
In the context of the present invention, phrase " is suitable for the location marker of advancing between the first stop surfaces and the second stop surfaces " and represents any relative motion comprising and location marker is moved to another stop surfaces from a stop surfaces, namely location marker self can such as static while the first stop surfaces and the second stop surfaces move.In addition, in the context of the present invention, term " location marker " comprises any structure of the well-defined relative motion that can experience between two stop surfaces.Particularly, this term not means any length-specific of this structure.Location marker can be such as or be included in the raised structures had on the component of first interface, or alternately, dosage arm rotatably locks relative to first interface component and can realize the non-rotating translational motion perpendicular to moving between the first stop surfaces and the second stop surfaces.
First stop surfaces can be arranged on the first dose-limiting structure, and the second stop surfaces can be arranged on the second dose-limiting structure.First dose-limiting structure can comprise the first connected structure and the second dose-limiting structure can comprise the second connected structure, and the first connected structure and the second connected structure can interlock to prevent the relative angular displacement between the first dose-limiting structure and the second dose-limiting structure.One or two in first dose-limiting structure and the second dose-limiting structure can longitudinally axis and extending.This longitudinal axis also can be rotation axis, and any relative angular displacement between the first dose-limiting structure and the second dose-limiting structure occurs around this axis.
First dose-limiting structure and the second dose-limiting structure relative to each other can correspond to the first position (wherein the first connected structure connects with the second connected structure with the relative angular displacement prevented between the first dose-limiting structure with the second dose-limiting structure) and the second axially displacement between position (wherein the first connected structure is separated with the second connected structure, thus allows the relative angular displacement between the first dose-limiting structure and the second dose-limiting structure) to axial corresponding to programmable state to axial of non-programmable state.This structure provides differentiation clear and definite between this two states, because only just allow the relative motion between the first dose-limiting structure and the second dose-limiting structure in a dimension after the relative localization of dose-limiting structure in another dimension.
First dose-limiting structure and the second dose-limiting structure can towards the first positions and being biased to axial.Thus, user must manipulate dosage setting apparatus consciously to switch to programmable state.This guarantees the adjustment that not inadvertently can not perform predetermined close.
Dosage setting apparatus can comprise user operable state and limit button, this button can start such as removable thus by the first dose-limiting structure and the second dose-limiting structure first to axial position and second switch between position to axial.Permission switches simply by this button between non-programmable state and programmable state, thus realizes the rapid adjustment of predetermined close.
Particularly, state limits button and can be combined with the second dose-limiting structure, and state limits button can be suitable for pressing the second dose-limiting structure with the bias force of antagonism from Compress Spring, thus by the first dose-limiting structure and the second dose-limiting structure from first to axial position be switched to the second position to axial.
First stop surfaces and the second stop surfaces can be biased toward each other, i.e. biased moment (such as from torsionspring), can constantly attempt the angular distance between both is minimized.In this case, when dosage setting apparatus being switched to programmable state (such as limiting button by down state), automatically predetermined close is reset.Then, presetting of new subscription dosage is performed to resist bias force by the angular distance increased between the first stop surfaces and the second stop surfaces, and release conditions can limit button when reaching desired amount, automatically dosage setting apparatus can be switched to non-programmable state thus, thus enable the first connected structure and the second connected structure that the first stop surfaces and the second stop surfaces are remained on restriction state.
Be connected to drug delivery system in response to dosage setting apparatus, dosage arm can be transformed into operation or duty from dormancy or dead status.Such as, such as dosage setting apparatus is being installed to period on drug delivery system, the mechanical interaction between a part of drug delivery system and a part of dosage setting apparatus can make dosage arm be transformed into running status from resting state.Particularly, by dosage setting apparatus is connected to drug delivery system, dosage arm can move to the position of rising from the position declined.
Therefore, resting state can be the state of the dosage arm corresponding with the non-working condition of dosage setting apparatus, and running status can be the state of the dosage arm corresponding with state in the use of dosage setting apparatus.
Such as utilize suitable power to apply component (as spring), dosage arm can be made to be biased towards resting state.But, in running status, except when beyond during adjacent second stop surfaces, by engaging with at least one in the first dose-limiting structure and the second dose-limiting structure, Avertable Dose wall turns back to resting state.Therefore, when being switched to running status, dosage arm will rest on running status, until it has arrived the second stop surfaces and has made dosage setting apparatus be separated with drug delivery system.In response to this, if dosage arm is biased towards resting state, dosage arm automatically will turn back to resting state.
Dosage arm keeps its running status until it arrives the fact of the second stop surfaces, allows user doses remaining part is directly transferred to another drug delivery system and doses remaining part is discharged from a rear device.Such as, if the first drug delivery system comprises content terminal mechanism, this mechanism prevents it to be set to carry the dosage D exceeding and stay in its medicine storage rdosage, and the predetermined close D of the programming of dosage setting apparatus during dosage setting step pmore than D rthe centre position that dosage arm will stop between the first stop surfaces and the second stop surfaces, this centre position corresponds to dosage Dr.If then dosage setting apparatus taken out from the first drug delivery system and be attached to the second drug delivery system, so continuous print dosage setting step enters the end position at the second stop surfaces by causing dosage arm from middle position row, sets D thus in the second drug delivery system p-D rthe dosage of size.Then the dosed administration of carry out desired in can arranging at two kinds, user need not calculate any remaining dosage and remember doses remaining set in the second drug delivery system.
Joint between at least one limiting structure in dosage arm and the first dose-limiting structure and the second dose-limiting structure can be included in the radial surface that a structural circumference in the first dose-limiting structure and the second dose-limiting structure extends, thus forms shelf and the clamping part on dosage arm being suitable for being connected with shelf.Dosage arm can be configured to longitudinally move (such as pure translation is moved or moved pivotally) between the position reduced and the position of rising, and is snapped on shelf when arriving the position raised.
First dose-limiting structure and the second dose-limiting structure can comprise circular-cylindrical portion separately, and these parts can be arranged in around the longitudinal axis of dosage setting apparatus coaxially.Second stop surfaces can comprise wall portion or another the outstanding structure in the circular-cylindrical portion of the second dose-limiting structure, and shelf can go out by the circumferential extension along the circular-cylindrical portion of the second dose-limiting structure from the back of wall portion or another outstanding structure, and in the end separated by a distance with transverse dimensions second stop surfaces corresponding to dosage arm clamping part.Acceptable dose arm once it arrives the second stop surfaces, is turned back to the position of reduction and dosage setting apparatus is separated with drug delivery system by this.
Dosage setting apparatus can comprise the shell portion body limiting hollow interior; One or more first dose-limiting structure, the second dose-limiting structure, first interface component, the second interface component and limiter component can be arranged in hollow interior.One or two in first dose-limiting structure and the second dose-limiting structure can rotate relative to shell portion body.In addition, one in first interface component and the second interface component can rotate relative to shell portion body, and another simultaneously in first interface component and the second interface component can rotate relative to shell portion body.As one example, first interface component can be arranged on inner rotary structure, and the second interface component can be arranged on the inwall of shell portion body.
Hollow interior can be suitable for the drug delivery system holding a part.Particularly, shell portion body can be the tubular structure being suitable for an end of axially receiving tubular syringe device altogether.
At least during dosage setting, the first stop surfaces and dosage arm can be biased toward each other, such as, via the torsionspring being arranged to work between the first dose-limiting structure and shell portion body.This will guarantee that dosage arm moves to dipping at the second stop surfaces from raised position, and dosage arm will automatically turn back to the first stop surfaces whenever being separated in response to drug delivery system and dosage setting apparatus.
Joint between at least one in dosage arm and the first dose-limiting structure and the second dose-limiting structure can be configured to bear and make dosage arm and the first stop surfaces towards each other and biased power, and the optional position making the dosage arm in its running status is settling position.This is by the fixing centre position of guaranteeing of the dosage arm provided particularly in segmentation administration, as mentioned above.
Such as, ratchet circumferentially can distribute along shelf, and dosage arm comprises projection, and this pop-up structure one-tenth engages with toothed shelf surface and is fastened on tooth when being subject to fully large driving force or moment.Adjacent tooth is separable reaches the distance corresponding with the dosage increment of adjustment of drug delivery system, make during dosage raises, the dosage that projection corresponds to an increment from a groove guides to the relative motion the dosage arm of adjacent grooves and shelf to be increased, and contrary, make dose degradation projection being corresponded to an increment during dosage is lowered from a groove guides to the relative motion between the dosage arm of adjacent grooves and shelf.When drug delivery system holds insulin product, amount adjustor increment such as can correspond to 1/2 or 1 iu (IU).
At least one in first stop surfaces and the second stop surfaces rotatably can connect with the second interface component via gear mechanism, makes the relative angular displacement between primary importance and the second position cause the first stop surfaces and/or relative angular displacement significantly less between the second stop surfaces and dosage arm.
A Non-exclusive examples of suitable gear mechanism is planetary gear.Shell portion body can be included in the central gear in hollow interior, and at least one in the first stop surfaces and the second stop surfaces rotatably can connect with the second interface component via at least one planetary gear engaged with central gear.
Particularly, shell portion body can comprise the longitudinally extending axis at center, and two or three gears (gear wheel) that this reel structure becomes to be arranged in inner rotary structure interact.These gears can with the mutual main body of the first dose-limiting structure, and whether be in non-programmable state or programmable state according to dosage setting apparatus, the second dose-limiting structure can via the first dose-limiting structure rotatably with these gear couplings.
The dosage of the size of the relative angular displacement between being incorporated to of gear mechanism can set and to require more than first outside and second outside of 360o, because can to cause between the first dose-limiting structure and first interface component according to this angular displacement of gear ratio and cause the relative angular displacement between the first stop surfaces and dosage arm thus, such as, be not more than 60o.Thus, gear mechanism allows to utilize dosage setting apparatus to programme and repeatedly setting in fact any predetermined close (in the dosage range provided by certain drug transmitting device).
In one particular embodiment of the present invention, there is provided a kind of dosage setting apparatus for the type drug delivery system, this dosage setting apparatus comprises: housing, be suitable for holding medicine medicine storage, can rotate relative to the housing of a part thus set the dosage of discharging medicine from medicine storage amount adjustor, amount adjustor responded relative to the rotation of a part for housing thus the dosage indicia of display setting dosage and for discharging the output mechanism setting dosage; This dosage setting apparatus comprises:
Limit the shell portion body of hollow interior, this hollow interior is suitable for the drug delivery system receiving a part,
First joint portion, this first joint portion to be disposed in hollow interior and to be configured to engage with a part for housing, thus prevents the relative rotation between the first joint portion and a part for housing, and relative rotary motion can be done relative to shell portion body in the first joint portion,
Second joint portion, this second joint portion rotatably lock relative to shell portion body and be configured to engage with amount adjustor thus prevent shell portion body and dosage regulate between relative rotation;
First dose-limiting structure, this structure comprises: the first displacement limiting surface, be disposed in hollow interior and can do the first dose-limiting structure of relative rotary motion relative to the first joint portion and the second joint portion;
Second dose-limiting structure, this structure comprises the second displacement limiting surface circumferentially spaced with the first displacement limiting surface; This second dose-limiting structure to be disposed in hollow interior and can to do relative rotary motion relative to the first joint portion and the second joint portion,
Location marker, this location marker rotatably lock relative to the first joint portion and can relative to the first dose-limiting structure and the second dose-limiting structure relative motion between the first displacement limiting surface and the second displacement limiting surface; And
Clutch mechanism, this clutch mechanism is configured in response to the relative rotary motion between the first joint portion and the second joint portion and causes the relative rotary motion between location marker and the first dose-limiting structure.
In another aspect of this invention, provide a kind of drug delivery system, this device comprises as the dosing mechanism described in any other side of the present invention and dose setter tool.Particularly, this drug delivery system can be the injection device with cylindrical or conical housing.Dosing mechanism can comprise amount adjustor.Dose display can operationally connect with amount adjustor, and is configured to show one group of dosage in response to amount adjustor relative to the current angle position of housing.
In another aspect of this invention, provide a kind of delivery system, this system comprises as the drug delivery system described in other side of the present invention and state change apparatus.Particularly, can provide a kind of comprise can show from this device discharge the type of one group of dosage of medicine drug delivery system and the state that is configured to be attached to separably drug delivery system change the system of apparatus, wherein drug delivery system comprises:
First is outside, and
Second is outside, and the first outside and the second outside can experience the relative angular displacement from the first relative position to the second relative position, and the second relative position limits one group of dosage of being discharged by drug delivery system, and wherein state change apparatus comprises:
First interface component, such as the first draw bail, be connected for interlocking with the rotation of the first outside,
Second interface component, such as the second draw bail, be connected for interlocking with the rotation of the second outside, first interface component and the second interface component can experience relative angular displacement, and
Limiter component, is suitable for limiting the relative angular displacement between first interface component and the second interface component.
Therefore, when state being changed apparatus and being attached to drug delivery system, the maximum possible relative angular displacement between limiter component limit first outside and the second outside.
Limiter component can be motion limiting mechanism, this mechanism comprise the location marker rotatably fixed relative to first interface component, the first abutment surface limiting the first extreme position that can suppose of location marker, with the mutual angular spacing of the first abutment surface and limit the second abutment surface of the second extreme position that location marker can be supposed.At least one in first abutment surface and the second abutment surface rotatably can connect with the second interface component.
Drug delivery system can comprise interchangeable or overall and not interchangeable medicine storage; This medicine storage has medicine outlet, and can cover this medicine outlet when state being changed the shell portion body of a part when apparatus is attached to drug delivery system.Therefore, user must remember that taking-up state changes apparatus from drug delivery system before beginning drug administration, and a kind of system is provided, wherein by dosage setting step clearly with dosage delivery step with separate, to avoid the process of any confusion or mistake.
In another aspect of this invention, provide a kind of delivery system, this system comprises:
Drug delivery system, this drug delivery system comprises the dosing mechanism setting dosage by causing the relative angular displacement between first component portion and second component portion; This dosing mechanism comprises the labelling for showing the one group dosage corresponding relative to the current angle position in second component portion with first component portion; And
Dosage setting apparatus, this dosage setting apparatus is removably attached to drug delivery system, and this dosage setting apparatus comprises: first that is configured to rotatably to lock relative in first component portion and second component portion when dosage setting apparatus being attached to drug delivery system and second that is configured to rotatably to lock relative to another in first component portion and second component portion when dosage setting apparatus being attached to drug delivery system;
Wherein first and second can be experienced relative angular displacement, and wherein dosage setting apparatus also comprises the dosage setting limiting member of the maximal phase diagonal displacement between restriction first and second.
Be described above the present invention, expect to provide a kind of scheme easily setting predetermined close.But, it should be noted, the present invention is equally applicable to guarantee that specific maximal dose sets, such as, allow health care professionals or another experimenter to preset dosage setting apparatus according to the content that this description is stated and set to prevent user the dosage exceeding certain level.Then can be set up to by user and comprise any dosage of predetermined maximal dose.
It should be noted, this description is not intended to the concrete structure that the state that is confined to changes apparatus.Although some shape can have the advantage compared to other shape, one skilled in the art can appreciate that the existence of the first coupling member, the second coupling member and limiter component does not cause any restriction to design state being changed to apparatus.
In this manual, the citation of each aspect or certain embodiment (such as " aspect ", " first aspect ", " embodiment ", " exemplary embodiment " etc.) is represented that specific feature, structure or characteristic in every respect or described in embodiment are included in or are subordinated at least one aspect of the present invention or embodiment, but need not comprise or be subordinated to all aspects of the present invention or embodiment.But, it is emphasized that the combination in any of various features, structure and/or characteristic described is in the present invention included in the present invention, unless clearly stated herein or pointed out contrary situation clearly in context.
Any and all examples or exemplary language (such as, such as etc.) use intention just illustrates the present invention and not applies restriction, requirement unless mentioned otherwise to scope of the present invention in the body of the email.In addition, the term in this description or word should not be understood as that and represent the requisite any key element not proposing patent protection of the invention process.
Accompanying drawing explanation
Further describe the present invention below with reference to accompanying drawings, wherein:
Fig. 1 a is the perspective view of system according to an illustrative embodiment of the invention, there is shown the dosage setting apparatus before being attached to medicament injection apparatus, wherein the dosage setting apparatus of a part has been taken out to show its inner and element,
Fig. 1 b rotates the injection device housing of 180 ° and the perspective view of dosage adjustment from the diagram of Fig. 1 a,
Fig. 1 c after being attached to injection device, the perspective view of dosage setting apparatus as shown in Figure 1a,
Fig. 2 is the longitudinal cross-section perspective view at the top of dosage setting apparatus,
Fig. 3 a is longitudinal cross-section fragmentary, perspective view after the resetting of initial or predetermined close, the dosage setting apparatus be in programmable state,
Fig. 3 b is the longitudinal cross-section fragmentary, perspective view being in the dosage setting apparatus in programmable state during predetermined close setting,
Fig. 4 shows the angular displacement between the stop surfaces in dosage setting apparatus,
Fig. 5 a shows before being attached to injection device, the dosage setting apparatus be in non-programmable state,
Fig. 5 b shows the dosage setting apparatus after being attached to injection device,
Fig. 5 c shows the dosage setting apparatus during the predetermined close setting of injection device,
Fig. 5 d show on injection device to the dosage setting apparatus that predetermined close adjusts,
Fig. 5 e shows immediately preceding the dosage setting apparatus after being separated with injection device,
Fig. 6 outlines the use of dosage setting apparatus in separate dose situation, and wherein predetermined close exceedes the final dose stayed in the injection device.
In the drawings, similar structure indicates with similar Reference numeral.
Detailed description of the invention
When using relative word such as " upwards " and " downwards " hereinafter, these words refer to accompanying drawing and need not refer to actual service condition.Shown accompanying drawing is schematic diagram, and wherein the structure of different structure and their relative dimensions intention are just for illustrative purposes.
Fig. 1 a is the perspective view of system according to an illustrative embodiment of the invention, there is shown and is being attached to the dosage setting apparatus before injection device 100.In this embodiment, dosage setting apparatus adopts the form of lid 1 and comprises tubulose shell portion body 2 and end face 3.The shell portion body 2 of a part is removed to show and be positioned at inner lid base portion 10 and cover base 30.Cover base 30 has corrugated end portion 31, and shell portion body 2 has the multiple recesses 8 circumferentially equidistantly distributed along its inwall.Button 6 is disposed in the center of end face 3.
Injection device 100 has the housing 101 holding cartridge case 102, and this cartridge case 102 holds the medicine of certain volume, such as blood sugar regulator (as insulin).The close end of housing 101 forms handle 108, this handle 108 holds the dial dose mechanism comprising dosage adjustable ring 103 and dose display 104, and dose display 104 is operationally connected to handle 108 and dosage indicia given in dose display 104 is changed around the rotation of the longitudinal axis of injection device 100 in response to dosage adjustable ring 103.Axially outstanding knob 107 is furnished with at the far-end of housing 101.Injection device 100 also comprises entry needle, and this entry needle is covered with the diaphragm of rubber 106 that can pierce through by retractible Needle shield 105 in this diagram.
By optionally action button 6, lid 1 can switch between two usual states (programmable state and non-programmable state).The diagram that wherein button 6 flushes with end face 3 reflects the non-programmable state of lid 1.By pressing the button 6, lid 1 is switched to programmable state.In programmable state, when lid 1 is attached to injection device 100 and on injection device 100 during adjust dosages, the internal part (not shown in fig 1 a) of lid 1 by occupy with through corresponding some relative position of adjust dosages.When reaching desired amount and non-programmable state is got back in lid 1 switching, described internals is locked in some relative position, thus lid 1 is programmed thus subsequently be used in injection device 100 during easily can reset predetermined close (desired amount regulated in advance) fast.The detail content of the programming about lid 1 is provided below.
Fig. 1 b shows and is in and the housing 101 of the opposite angles in Fig. 1 a and dosage adjustable ring 103.Especially, can see that dosage adjustable ring 103 has projection 109.
Fig. 1 c shows the lid 1 being attached to injection device 100.The remove portion of shell portion body 2 shows now and to interlock with the rotation between housing 101 be connected by engaging the cover base 30 that provides between knob 107 with corrugated end portion 31.At this lid 1 with the coupled situation of injection device 100, projection 109 engages with a recess 8, thus provides shell portion body 2 not shown with dosage adjustable ring 103() between rotation interlock and be connected.
Fig. 2 is the longitudinal cross-section perspective view of the upper of lid 1 or close end, shows in detail the structure of predetermined close set mechanism in figure.This there is shown the lid 1 being in the state being wherein attached to injection device 100.But, for the sake of clarity, injection device 100 is omitted from this diagram.
Integrally formed with shell portion body 2 and end face 3 is central shaft 4, and this central shaft 4, from end face 3 to downward-extension, reserves the clearance 7 for the axial movement of button 6.Central shaft 4 is connected to cover base 30 so that inside cover base 30 being axially fixed on shell portion body 2 allows shell portion body 2 and the relative rotation between cover base 30 simultaneously at its far-end.Central shaft 4 has through hole 5, and this through hole 5 is suitable for receiving the tube of button 6 and making its stabilisation.The distal portion of central shaft 4 is formed as gear and is suitable for the interaction with one group of spur gear 33.In the present embodiment, three spur gear 33 displacement 120o each other.The stud 32 that each spur gear 33 is suitable for around being arranged on cover base 30 proximal end face rotates.Spur gear 33 engages with the internal gear 15 in lid base portion 10, therefore, it is possible to by the rotary motion transmission of shell portion body 2 to lid base portion 10.Select gear ratio to guarantee in the programmable state of lid 1, setting is once advanced the relative angular displacement can carried between shell portion body 2 needed for maximal dose and cover base 30 from injection device 100, causes being less than the lid base portion 10 of 360 ° and lid from the relative angular displacement between metal elements 20.
The dose limitation device 40 with annular base 41 is disposed in central shaft 4 around.Connecting portion 42 radially stretches out from base portion 41 and has axial arm 43.Arm 43 axially extends down through the opening cover base 30 proximal end face from connecting portion 42, and it is not shown to end at the injection device 100(be suitable for a part) abutment surface 45 of far-end that is connected.Arm 43 also axially upwards extends from connecting portion 42, and ends at and be suitable for and covering the near-end hook 44 engaged from the peripheral shelf 27 metal elements 20.
Compress Spring 50 is disposed in the surrounding of central shaft 4 and is arranged in base portion 41 and lid between the end difference of metal elements 20, thus makes dose limitation device 40 biased downward and make lid from metal elements 20 to upper offset.Driving spring 60 is arranged to apply moment between shell portion body 2 and lid base portion 10.During dosage setting, driving spring 20 is strained by injection device 100.Back-moving spring 70 is arranged between metal elements 20, apply moment at lid base portion 10 and lid.During the programming of predetermined close, in the programmable state of lid 1, back-moving spring 70 is strained.
In fig. 3 a, illustrate the lid base portion 10 of shell portion body 2 and a part at aperspective cross section, other parts all are shown in standard perspective figure simultaneously.For the sake of clarity, all springs are removed.Shown in the drawings of to be attached to injection device 100(not shown) after but before the actual program of predetermined close, the lid 1 be in programmable state.Lid base portion 10 has cylindrical wall 11, the cut initial sheet 13 of advancing being defined for dose limitation device 40 with display towards this projection 12 of interior vertical protrusion 12(of wall 11 of a part) and the end surfaces 23 of advancing of dose limitation device 40 is defined in lid this projection 12 of vertical protrusion 22(toward the outside from the cylinder-shaped body 21 of metal elements 20).In the shown position of lid 1, initial sheet 13 reaches the distance corresponding with the width of arm 43 with end surfaces 23 is circumferentially spaced, that is, before the programming of predetermined close, arm 43 is sandwiched between initial sheet 13 and end surfaces 23.
Cylinder-shaped body 21 is connected to the cervical region 25 with cylindrical end face 26 from the end difference of metal elements 20 by lid, utilizes button 6 to act on this cylindrical end face 26 thus raised circle 24 is separated with the raised annulus 14 on lid base portion 10 in the shown position of lid 1.Thus, cover and relative angular displacement can occur from metal elements 20 and lid base portion 10.Shelf 27 possesses tooth 28 along its whole upper surface, for interacting with the one or more projections (not shown) downward on hook 44.
Fig. 3 b shows the lid 1 during the programming of predetermined close.That lid 1 is attached to injection device 100(is not shown) time, shell portion body 2 is rotated counterclockwise around longitudinal axis, thus causes relatively little the turning clockwise of lid base portion 10, makes initial sheet 13, relative to arm 43 and end surfaces 23, angular displacement occur thus.
Fig. 4 shows and to programme to predetermined close and the angular distance θ formed between initial sheet 13 and end surfaces 23 after lid 1 is switched to non-programmable state, wherein raised circle 24 engages with raised annulus 14, thus lid is rotatably locked onto lid base portion 10 from metal elements 20.In the plane of the longitudinal axis perpendicular to lid 1, measured angular is apart from θ.
Fig. 5 a-Fig. 5 e shows after the programming of predetermined close and during being used in injection device 100, the lid 1 be under different situation.In " use of dosage setting apparatus " joint, different situation is described below.Can find out from Fig. 5 a, shelf 27 does not go out to extend from vertical projection 22 and reaches 360o but end at the distance corresponding with the width of arm 43 of being separated by with end surfaces 23, forms space 29 thus thus only realizes the axial passage of the hook 44 above shelf 27 below shelf 27 when arm 43 abutting end surface 23.
Fig. 6 outlines the use in lid 1 separate dose situation, wherein to programme the final dose made it exceed to stay in injection device 100 to predetermined close.This there is shown particular condition wherein cartridge case 102 have 10 units by the accommodation medicine of administration and wherein to programme to lid 1 thus to set the dosage being greater than 10 units.During the setting of 10 units, lid 1 is used in injection device 100 and has caused it to move to new injection device 200 to be up to dosage that is predetermined or programming by doses remaining section sets.Below this mechanism of the use realizing lid 1 is described in detail.
The use of system
The use of lid 1 in injection device 100 is described below.In order at every turn enable user promptly set same dose when needs drug administration, must programme to lid 1 by dosage first for this reason.This is as described in Fig. 3 a and Fig. 3 b, above far-end that lid 1 is placed in injection device 100 or needle end part, presses the button 6 and makes shell portion body 2 rotate relative to handle 108 and complete.During lid 1 is attached to injection device 100, knob 107 is received in the groove of corrugated end portion 31, and projection 109 is received in a recess in the recess 8 of multiple circumference distribution, thus cover base 30 is rotatably locked onto housing 101 and shell portion body 2 is rotatably locked onto dosage adjustable ring 103.In addition, utilize Needle shield 105 that dose limitation device 40 is axially brought up to operating position from rest position, to resist the bias force from Compress Spring 50.
Pressing of button 6 causes lid to reach the distance equal with clearance 7 from metal elements 20 axial displacement, with the bias force of antagonism from Compress Spring 50, make raised circle 24 be separated with raised annulus 14 thus, therefore make lid be separated with lid base portion 10 from metal elements 20.Shell portion body 2 makes central shaft 4 make spur gear 33 and make to cause lid base portion 10 thus to turn clockwise by internal gear 15 relative to being rotated counterclockwise of handle 108.This relative angular displacement between shell portion body 2 and lid base portion 10 is strained driving spring 60 and stores energy in wherein.Because lid is separated from metal elements 20 with lid base portion 10, so shell portion body 2 is initial sheet 13 clockwise angular displacements relative to both dose limitation device 40 and end surfaces 23 relative to the result be rotated counterclockwise of handle 108.Back-moving spring 70 to be strained from this relative angular displacement between metal elements 20 and is stored energy in wherein by lid base portion 10 and lid.Side by side, the dosage adjustable ring 103 driven by shell portion body 2 experiences relative to the relative rotation of cover base 30 with housing 101, thus causes the dosage indicia in dose display 104 to increase dose counting.When the release-push 6 when dose display 104 sees desired amount, thus Compress Spring 50 forces raised circle 24 to get back to the state engaged with raised ring part 14, thus rotatably lid is locked onto lid base portion 10 from metal elements 20.Point at this moment, initial sheet 13 reaches the fixed angles corresponding with utilizing the desired amount of lid 1 repeatedly setting apart from θ with end surfaces 23 is spaced, and therefore given dose is programmed to lid 1 for this reason.When subsequently lid 1 being removed from injection device 100, Compress Spring 50 is utilized to make dose limitation device 40 automatically be reduced to its rest position, driving spring 60 discharges its energy stored thereupon, thus automatically makes lid base portion 10 and lid be rotated counterclockwise until initial sheet 13 adjoins arm 43 from metal elements 20.Now, lid 1 can be utilized on injection device 100 and easily set dosage that is predetermined or programming, as will be described below.
When carrying out the administration from the setting dosage cartridge case 102, dose display being reset and can new dosage be set.If expect the dosage of setting and former equal sizes, lid 1 is only needed again to be attached to injection device 100, make corrugated end portion 31 engage with knob 107 thus, recess 8 engages with projection 109 and utilizes Needle shield 105, along initial sheet 13, dose limitation device 40 is axially brought up to from the rest position lower than shelf 27(Fig. 5 hook 44 a) operating position (Fig. 5 b) that wherein hook 44 engages with tooth 28.Tensioning Compress Spring 50 storing energy in wherein thus.Between the moving period of dose limitation device 40, the flexible construction a little provided by connecting portion 42 causes arm 43 radially to extrinsic deflection, and when dose limitation device 40 arrives operating position, and arm 43 radially allows hook 44 to be snapped on shelf 27 to intrinsic deflection.
Utilize and be activated now dose limitation device 40, user makes shell portion body 2 be rotated counterclockwise (Fig. 5 c) relative to handle 108.Because gear mechanism and lid 1 are in non-programmable state, thus lid base portion 10 and lid turn clockwise from metal elements 20, and therefore when arm 43 is advanced towards end surfaces 23, hook 44 is fastened on above tooth 28.Relative motion between shell portion body 2 and lid base portion 10 is strained driving spring 60 and stores energy in wherein.Any special concern is paid in the change of dosage indicia in not to dose display 104, user makes shell portion body 2 rotate relative to handle 108 until cannot further rotate simply, corresponding when this and arm 43 move to and adjoin with end surfaces 23 (Fig. 5 d).Point at this moment, dose limitation device has experienced relative to lid base portion 10 and has covered from metal elements 20 from initial sheet 13 to the relative motion of end surfaces 23, and this dosage adjustable ring 103 dosage needed for equal with predetermined close to setting is relevant with the relative motion between housing 101.In other words, lid 1 is attached to injection device 100 and shell portion body 2 is rotated relative to handle 108 until feel and set desired amount thus by obvious retainer by user simply.
Present lid 1 is separated with injection device 100, thus under the effect of Compress Spring 50 Needle shield 105 from abutment surface 45 and arm 43 slide downward through space 29(Fig. 5 e).When hook 44 arrives the rest position below shelf 27, driving spring 60 discharges its energy stored and lid base portion 10 and lid is rotated counterclockwise until arm 43 adjoins initial sheet 13(Fig. 5 a) from metal elements 20.Therefore, lid 1 automatically prepares new dosage and regulates when being separated with injection device 100, suppose to set the dosage equal with predetermined close.
When staying the set dosage in cartridge case 102 and being less than predetermined close, content in injection device 100 terminate mechanism during dosage setting, preventing arm 43 is arrived end surfaces 23(because it will prevent dosage adjustable ring 103 further rotating relative to housing 101) and cause on the contrary arm 43 occupy along shelf 27 between initial sheet 13 and end surfaces 23 centre position, such as correspond to Fig. 5 c.When then taking out lid 1 from injection device 100, arm 43 will rest on centre position, because shelf 27 prevents Compress Spring 50 from making dose limitation device 40 axially move downward, and one or more projection on hook 44 and the interaction between tooth 28 prevent driving spring 60 from making lid base portion 10 and covering to rotate from metal elements 20 relative to dose limitation device 40.
Lid 1 can be attached to new injection device 200 by user now, and by make in a manner similar to that described before shell portion body 2 around the longitudinal axis of injection device 200 rotate until feel when arm 43 arrives end surfaces 23 obvious retainer time and set the doses remaining be contained in wherein transferred out from cartridge case 202 simply.Then, can give predetermined close with the form of separate dose, wherein first is to be carried by injection device 100 and remainder is carried by injection device 200.Thus, medicine is not wasted and user need not calculate and remember on new injection device 200 set doses remaining.
At any time, by pressing the button 6, lid can be separated with lid base portion 10 from metal elements 20, and change predetermined close.If lid 1 is attached to injection device 100 when pressing the button 6, then can transfer optionally increase or reduce predetermined close relative to counterclockwise, the dextrorotation of handle 108 respectively by shell portion body 2.If make lid 1 be separated with injection device 100, then when pressing the button 6, back-moving spring 70 will discharge its energy stored and vertical protrusion 12 and vertical protrusion 22 be promoted toward each other, thus is clipped between initial sheet 13 and end surfaces 23 by arm 43.Thus, automatically lid 1 is rearranged into the non-programmed state shown in Fig. 3 a.

Claims (19)

1. the drug delivery system (100) comprising the type of one group of dosage that can show from the medicine be wherein discharged and the state being configured to be attached to separably described drug delivery system (100) change a system for apparatus (1),
Wherein said drug delivery system (100) comprising:
First outside (107), and
Second outside (109), described first outside (107) and described second outside (109) can experience the relative angular displacement from the first relative position of the first state limiting described drug delivery system (100) to the second relative position of the second state of the described drug delivery system of restriction (100), and
Wherein said state changes apparatus (1) and comprising:
First draw bail (31), described first draw bail (31) is configured to fix relative to the rotation of described first outside (107),
Second draw bail (8), described second draw bail (8) is configured to fix relative to the rotation of described second outside (109), and described first draw bail (31) and described second draw bail (8) can experience relative angular displacement, and
Limiters mechanisms, described limiters mechanisms is suitable for the maximum of the relative angular displacement limited between described first draw bail (31) and described second draw bail (8).
2. the system as claimed in claim 1, wherein said drug delivery system (100) also comprises housing (101) and amount adjustor (103), described amount adjustor (103) can rotate relative to described housing (101) thus set the dosage that transfers out from described drug delivery system (100), and wherein said first outside (107) rotates fixing relative to described housing (101) and described second outside (109) rotates fixing relative to described amount adjustor (103).
3. system as claimed in claim 1 or 2, wherein said state change apparatus (1) is also included in one end and opens and tubulose shell portion body (2) with hollow interior, and described hollow interior is configured to when described state being changed the described drug delivery system (100) holding a part when apparatus (1) is attached to described drug delivery system (100).
4. system as claimed in claim 3, wherein said drug delivery system (100) comprises the medicine storage (102) with medicine outlet, and wherein covers described medicine outlet when described state being changed described shell portion body (2) of a part when apparatus (1) is attached to described drug delivery system (100).
5. as the system in Claims 1-4 as described in Arbitrary Term, wherein said first draw bail (31) is configured to rotate during interlocking connects first engages with described first outside (107), and described second draw bail (8) is configured to rotate during interlocking connects second engage with described second outside (109) in multiple relative angle orientation at described state change apparatus (1) and described drug delivery system (100).
6. system as claimed in claim 5, one in wherein said first draw bail (31) and described first outside (107) comprises the spaced first interface structure of multiple circumference, and another in described first draw bail (31) and described first outside (107) comprises and is suitable for one or more joint in the first interface structure spaced with described multiple circumference or the adjacent first special geometry, and wherein, one in described second draw bail (8) and described second outside (109) comprises the second spaced interface structure of multiple circumference, and another in described second draw bail (8) and described second outside (109) comprises and is suitable for one or more joint in the second interface structure spaced with described multiple circumference or the adjacent second special geometry.
7., as the system in claim 1 to 6 as described in Arbitrary Term, wherein said limiters mechanisms comprises: relative to described first draw bail (31) spin locking location marker (43), limit the first extreme position of described location marker (43) the first abutment surface (13) and with described first abutment surface (13) angular spacing and limit second abutment surface (23) of the second extreme position of described location marker (43); At least one in described first abutment surface (13) and described second abutment surface (23) connects rotatably with described second draw bail (8).
8. system as claimed in claim 7, wherein said state changes apparatus (1) and can switch between non-programmable state and programmable state, in described non-programmable state, described first abutment surface (13) and described second abutment surface (23) relative to each other lock rotatably, in described programmable state, described first abutment surface (13) and described second abutment surface (23) can relative rotary motion.
9. system as claimed in claim 8, wherein described first abutment surface (13) is arranged in the first dose-limiting structure (10) go up and described second abutment surface (23) is arranged on the second dose-limiting structure (20), described first dose-limiting structure (10) comprises the first connected structure (14) and described second dose-limiting structure (20) comprises the second connected structure (24), and wherein, described first dose-limiting structure (10) and described second dose-limiting structure (20) be arranged to coaxially around longitudinal axis and can first to axial position and second there is displacement to axial between position to axial, in described first to axial position, described first connected structure (14) and described second connected structure (24) combine with the relative angular displacement prevented between described first dose-limiting structure (10) and described second dose-limiting structure (20), in described second to axial position, described first connected structure (14) is separated with described second connected structure (24), allow the relative angular displacement between described first dose-limiting structure (10) and described second dose-limiting structure (20) thus.
10. system as claimed in claim 9, wherein said state changes apparatus (1) and also comprises user operable state and limit button (6), described button (6) can start thus by described first dose-limiting structure (10) and described second dose-limiting structure (20) described first to axial position and described second switch between position to axial.
11. systems as described in claim 9 or 10, wherein said first abutment surface (13) and described second abutment surface (23) are biased toward each other.
12. as the system in claim 9 to 11 as described in Arbitrary Term, wherein, described location marker (43) is transformed into running status in response to described state change apparatus (1) is attached to described drug delivery system (100) from resting state, and wherein said running status, before described second extreme position of arrival, prevent described location marker (43) from turning back to described resting state by engaging with at least one in described first dose-limiting structure (10) and described second dose-limiting structure (20).
13. systems as claimed in claim 12, wherein said location marker (43) is biased towards described resting state, and wherein when when described second extreme position, described location marker (43) in response to described state changes apparatus (1) and being separated of described drug delivery system (100) from described running state conversion to described resting state.
14. systems as described in claim 12 or 13, wherein utilize biased moment that described first abutment surface (13) and described location marker (43) are biased toward each other, and wherein said location marker (43) is suitable for resisting described biased moment with the joint of at least one in described first dose-limiting structure (10) and described second dose-limiting structure (20).
15. systems as claimed in claim 14, wherein said location marker (43) and the joint of at least one in described first dose-limiting structure (10) and described second dose-limiting structure (20) comprise the combination provided by the ratchet (28) that radially extensional surface (27) circumference distributes, and wherein adjacent tooth (28) separation increases relevant distance to the amount adjustor of described drug delivery system.
16. as the system in claim 7 to 15 as described in Arbitrary Term, at least one in wherein said first abutment surface (13) and described second abutment surface (23) to rotate with described second draw bail (8) via gear mechanism and connects, and described gear mechanism reduces the ratio of the relative angular displacement between described first abutment surface (13) and described location marker (43) and the relative angular displacement between described first draw bail (31) and described second draw bail (8).
17. systems as claimed in claim 16, when being subordinated to claim 3, wherein said shell portion body (2) has described second draw bail (8) and has the central gear (4) in described hollow interior, and wherein said first abutment surface (13) rotates with described second draw bail (8) via at least one spur gear (33) engaged with the internal gear (15) of described central gear (4) and described first dose-limiting structure (10) and connects.
18. 1 kinds are used in as the state in the system in claim 1 to 17 as described in Arbitrary Term changes apparatus (1).
19. 1 kinds are used in as the drug delivery system (100) in the system in claim 1 to 17 as described in Arbitrary Term.
CN201380067067.0A 2012-12-21 2013-12-20 State change apparatus for drug delivery system Expired - Fee Related CN105025960B (en)

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US10117996B2 (en) 2018-11-06
JP6318170B2 (en) 2018-04-25
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CN105025960B (en) 2018-01-23
US20190038841A1 (en) 2019-02-07

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